EP4167902A1

EP4167902A1 - Medical device and method of detecting a change of position

Info

Publication number: EP4167902A1
Application number: EP21740122.3A
Authority: EP
Inventors: Hamid Lamraoui; Benjamin ROUSTAN
Original assignee: Uromems SAS
Current assignee: Uromems SAS
Priority date: 2020-06-19
Filing date: 2021-06-17
Publication date: 2023-04-26
Also published as: US20230320830A1; WO2021255388A1; FR3111539B1; FR3111539A1

Abstract

A medical device (1) designed to be implanted in the body of a person or animal, which device comprises a housing (2), at least one deformable element (3) and at least one sensor for measuring or calculating pressure, the housing (2) and the deformable element (3) being connected by a tubular connection (5) and implanted in the body of a person or animal at a distance from each other, the medical device (1) being characterised in that it is configured to detect a position and/or a change of position of at least one part of the body depending on a variation in the pressure measured or calculated by the sensor.

Description

L

MEDICAL DEVICE AND CHANGE DETECTION METHOD

POSITION

FIELD OF THE INVENTION The present invention relates to a medical device implantable in a human or animal body.

The invention relates in particular to active implantable medical devices, that is to say medical devices dependent for their operation on a source of electrical energy and their configuration for the detection of a change in position of at least part of the human or animal body.

STATE OF THE ART

There are many implantable medical devices to perform a function in the patient's body, for example to overcome the dysfunction of a natural organ such as that of a sphincter in the case of urinary incontinence or to act by applying a particular therapy. as is the case with a pacemaker or neurostimulator.

In particular, the case of urinary incontinence is a handicap that affects both women and men. This disability can be defined as an involuntary loss of urine through the urethra. In most cases, this is due to a weakened pelvic support or bladder / sphincter block. Depending on the symptoms, there are solutions that do not require surgery, such as rehabilitation or drug treatments. When these methods are not sufficient, incontinence is said to be "severe" and then requires the fitting of a prosthesis to allow the patient to return to normal social life. In severe incontinence, the most common method is to put in place an artificial urinary sphincter.

There are known implantable medical devices intended to selectively close an anatomical duct, for example to remedy incontinence (the case of artificial urinary and anal sphincters). The obstruction of the anatomical duct is generally caused by the compression exerted by a cuff wrapped around said duct.

Today's most popular artificial urinary sphincter consists of a passive silicone elastomer hydraulic system made up of three main parts.

The first part consists of a deformable element of the occlusive cuff type placed around the urethra, possibly the bladder neck during implantation in a woman, exerting a circumferential urethral pressure thanks to a cushion filled with liquid thus ensuring the patient's continence. . The second is a regulation balloon which, when filled with a certain volume of liquid, creates a constant hydraulic pressure. The regulation pressure is chosen according to the patient during the operation, this cannot be changed once the prosthesis has been implanted. Finally, a manual pump is needed, the third part, ensuring the opening of the urethral part compressed by the cuff. This pump is composed of a bulb, a resistor and two valves which ensure the circulation of the liquid towards or from the occlusive cuff. When the patient feels the need to urinate, he squeezes the bulb located on the lower part of the pump, the fluid is transferred from the cuff to the regulation balloon: the pressure exerted on the urethra then becomes negligible compared to the bladder pressure . Urine can then flow freely out of the bladder. In practice, a few minutes later, the liquid is transferred from the balloon to the cuff thanks to the pressure exerted on the resistor by the regulation balloon, the urethra is again occluded.

This passive prosthesis has a number of drawbacks.

First, the regulating pressure of the cuff can only be adapted when the prosthesis is placed, which could cause problems if the pathology evolves over time so that the pressure in the urethra should be modified to meet the needs of the patient or even when there is a change in posture or physical activity that may result in varying pressure on the sphincter and cuff.

In addition, this system does not offer satisfactory comfort because the patient must actuate the pump whenever necessary, the control being moreover not easy since it is necessary to maintain the pump manually during urination. on the one hand and squeezing it with force on the other. This is all the more problematic since the control pump is located in men in the scrotum and in women in one of the labia majora.

Finally, the operation of this prosthesis involves significant compression of the urethra almost continuously, regardless of the posture and the level of compression required, which can induce urethral atrophies. This is because the prosthesis only works with one urethral pressure, it must be high enough to prevent leaks, which can eventually damage the urethra.

In addition, for urination to be possible, the patient must contract their bladder sufficiently to combat the resistance created in the urethra by the prosthesis. In addition to the drawback mentioned above of almost continuous compression of the urethra regardless of the posture, the effort required for urination with this type of prosthesis creates a kind of artificial prostate adenoma which can have serious consequences for the patient. patient.

Finally, there are reliability problems with the elements constituting the prosthesis itself, in particular the pump and hydraulic circuit assembly.

These drawbacks of existing artificial urinary sphincters mean that these prostheses are only used to treat severe urinary incontinence. Consequently, artificial urinary sphincters are not used for patients suffering from low incontinence and they are not suitable for all situations and postures. Indeed the latter prefer to undergo the discomfort caused by their pathology.

Alternative active devices have been developed in an attempt to remedy some of these drawbacks, in particular by providing electronic controls for the prosthesis.

Among these different types of implanted medical devices, some include posture sensors of the human or animal body so as to adapt the pressure exerted on the natural duct by the occlusive cuff. Adapting the pressure exerted is essential to remedy the drawbacks described above and to manage stress incontinence, that is to say when the patient exercises an activity which causes a variation in pressure on his body. urethra and on the cuff, or to reduce the pressure when the patient is lying down at rest so as not to stress the urethra unnecessarily which could cause, as explained, atrophy in the long term.

For this purpose, it becomes necessary to detect the position of the patient and to adapt the pressure exerted, otherwise the organs will undergo significant deterioration or to adapt the therapy applied according to the position of the patient.

For example, the detection of the position of the body can be carried out by means of an accelerometer provided in the medical device. The accelerometer can thus measure an acceleration in particular gravitational in one or preferably three directions making it possible to discriminate different postures of the patient's body. Then by comparison with reference values and calculations of variation of angle values, we can deduce a position of the body. However, the use of accelerometers for these purposes leads to results which may show relative reliability and significant inaccuracies, in particular in the case of migration or rotation of the implanted medical device.

DISCLOSURE OF THE INVENTION

The aim of the present invention is therefore to remedy the drawbacks detailed above by proposing an implantable active medical device and a position detection method which is more reliable and more robust over time.

To this end, the present invention provides a medical device designed to be implanted in a human or animal body, comprising a housing, at least one deformable element, a tubular connection providing a fluid connection between the housing and the deformable element to form a fluid circuit. , and at least one sensor capable of measuring or calculating a pressure in the fluidic circuit, the housing and the deformable element being adapted to be implanted in the human or animal body distant from one another, the medical device being characterized in that it is configured to detect a position and / or a change in position of at least a part of said body as a function of a variation in the pressure measured or calculated by the sensor.

Preferably, the detection of a position and / or a change of position of at least a part of the body corresponds to the detection of a posture and / or a change of posture of said body. In what follows, we will therefore mainly describe the postures and posture changes.

However, it is understood that the following may also apply to a change in position of only one part of the body. For example, the device according to the invention is able to detect the position of a prosthesis of a mechatronic leg. Its movement can therefore be adapted accordingly.

According to one embodiment of the invention, the housing is rigid and hermetically connected to one end of said tubular connection.

According to one embodiment of the invention, the deformable element is inflatable.

According to one embodiment of the invention, the sensor is arranged inside the housing and able to measure or calculate the pressure in the deformable element.

According to a particular embodiment of the invention, the housing comprises a fluid reservoir including a movable part and an actuator of the movable part to vary a volume of said reservoir, the sensor capable of measuring or calculating the pressure being mechanically linked to said movable part and / or to the actuator, in particular integrally.

According to one embodiment of the invention, the housing and the deformable element are adapted to be implanted in the human or animal body distant from each other in a direction which varies during a change of position of. at least part of said body, in particular when going from a standing to lying down position. Preferably, the housing and the deformable element are adapted to be implanted in the human or animal body distant from each other in a direction substantially equivalent to a longitudinal direction of said body. Still preferably, the housing and the deformable element are adapted to be implanted in the human or animal body distant from each other by a distance of at least 5 cm, preferably by a distance of at least 5 cm. at least 10 cm, more preferably from a distance of at least 20 cm.

According to a particular embodiment of the invention, the device comprises a position sensor of at least part of said human or animal body.

According to a particular embodiment of the invention, the device comprises a position sensor of at least one part of the human or animal body, the device being configured to detect the position and / or the change of position of at least one part of said body from a measurement or calculation of pressure by the sensor capable of measuring or calculating the pressure and for confirming said position and / or said change of position from a measurement of the position sensor. According to another particular embodiment of the invention, the device comprises a position sensor of at least one part of the human or animal body, the device being configured to detect the position and / or the change in position of at least a part of said body by the position sensor and to confirm said position and / or said change of position from a measurement or calculation of the pressure in the fluidic circuit by the sensor capable of measuring or calculating the pressure.

In one embodiment of the invention, the position sensor is chosen from: an accelerometer, in particular an accelerometer arranged to calculate linear accelerations along three orthogonal axes, a gyroscope and / or an inclinometer.

In one embodiment of the invention, the device comprises a control unit configured to perform at least one of the following operations:

- measure or calculate a pressure by means of the sensor capable of measuring or calculating a pressure,

- detecting a position or a change in position of at least part of said body as a function of a position sensor and / or of the sensor capable of measuring or calculating the pressure.

In one embodiment of the invention, the control unit is configured to control the actuator to move the movable part of the reservoir and to vary the volume of said reservoir.

According to a particular embodiment of the invention, the deformable element is an occlusive cuff configured to close off a natural duct of said human or animal body. Preferably, the device is configured to be implanted in a human or animal body in order to close a natural duct of said human or animal body included among at least: a urethra, a gastric duct, a colon or a rectum.

According to a particular embodiment of the invention, the device is configured to act as a pacemaker or as a neurostimulator.

The invention extends to a method for detecting a position and / or a change in position of at least a part of a human or animal body, in which said body comprises a medical device comprising a housing, at least one deformable element, a tubular connection providing a fluid connection between the housing and the deformable element to form a fluidic circuit, and at least one sensor capable of measuring or calculating a pressure in the fluidic circuit, the housing and the deformable element being arranged at a distance from each other, in which a position and / or a change in position of at least part of said body is detected as a function of a variation in the pressure measured or calculated by the sensor capable of measure or calculate a pressure.

In one embodiment of the method according to the invention, the housing and the deformable element in the human or animal body are distant from each other in a direction which varies during a change of position of at least one. at least part of said body, in particular when going from a standing to lying position. In another embodiment of the method according to the invention, the housing and the deformable element in the human or animal body are distant from each other in a direction substantially equivalent to a longitudinal direction of said body.

In yet another particular embodiment of the method according to the invention, the medical device is fitted with a configured control unit which performs at least one of the following operations:

- detecting a position and / or a change in position of at least part of said body as a function of a position sensor and / or of the sensor capable of measuring or calculating the pressure.

In another embodiment of the method according to the invention, the control unit is configured to control an actuator to move a movable part of a reservoir and to vary the volume of said reservoir.

In another embodiment of the method according to the invention, the deformable element is inflatable and chosen from an occlusive cuff arranged to close a natural duct of said human or animal body, a penile prosthesis or a deformable element configured to limit an entry. of food in a stomach of the human or animal body.

In another particular embodiment of the method according to the invention, a position sensor capable of detecting a position and / or a change in position of at least one part of the body is calibrated by means of the sensor capable of measuring or calculating. a pressure.

Finally in another particular embodiment of the method according to the invention, the deformable element is inflatable and chosen from an occlusive cuff arranged to close a natural duct of said human or animal body.

DESCRIPTION OF FIGURES

Other characteristics and advantages of the invention will emerge from the detailed description which follows, with reference to the accompanying drawings in which:

- Figure 1 illustrates a schematic view of a medical device of the artificial sphincter type according to an exemplary embodiment of the invention;

- Figure 2 illustrates a schematic view of the position of the medical device of Figure 1 implanted in the human body seen from the front;

- Figure 3 illustrates a detailed view of the medical device implanted in the body of a man in a standing position seen in profile;

- Figure 4 illustrates a detailed view of the medical device implanted in the body of a man in the supine position seen in profile; - Figure 5 illustrates the detection method according to the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Figure 1 schematically illustrates the medical device 1 according to the invention according to an exemplary embodiment in which it corresponds to an artificial urinary sphincter intended to combat incontinence.

The medical device 1 generally comprises a rigid casing 2 and a deformable element 3. In this example the deformable element 3 consists of an inflatable occlusive cuff arranged around at least part of a natural duct 4 of the human body. or animal, the urethra in this case. The cuff is preferably made of a biocompatible elastomeric material, for example silicone.

The housing 2 and the occlusive cuff 3 are connected by a tubular connection 5 and are in fluid connection, that is to say that the medical device 1 is arranged to move fluid in variable volume from the housing to the cuff and vice versa. It is a hydraulically operated device.

The housing 2 comprises a fluid reservoir 6 with variable volume. The reservoir 6, the tubular connection 4 and the occlusive cuff 3 are all three fluidly connected so as to form a single fluidic circuit.

The reservoir 6 comprises a fixed part 7 and a movable part 8. The movable part 8, during its displacement, varies the volume of fluid in the reservoir to transfer it from the reservoir 6 to the occlusive cuff 3, which then inflates, increasing. pressure to occlude the duct. Conversely, a displacement of the movable part 8 in the opposite direction leads to an increase in the volume of the reservoir, and therefore a transfer of fluid from the cuff 3 to the reservoir 6. This has the effect of releasing the pressure on the urethra and thus to allow urination.

The movable part 8 of the reservoir 6 is mechanically coupled and driven by an actuator 9 to produce a linear displacement with respect to the fixed part 7 so as to adjust the volume of the reservoir.

The actuator 9 can in particular include an electromagnetic motor and a reduction gear. The actuator is controlled by a control unit 10 described in detail below and powered by a power source (not shown), rechargeable or not. In a particular configuration, the energy source is outside the human body and transmits energy wirelessly to the medical device 1.

The unit 10 is called the control unit, but it is understood that it performs both control functions, control functions and calculation functions, as will appear in the following.

In addition, according to the invention, it is provided that the housing 2 also includes a sensor 11 capable of measuring or calculating the pressure in the fluid circuit. The sensor 11 measures either directly the pressure exerted or a force exerted and the control unit 10 then calculates the corresponding pressure. In the latter case, the sensor 11 is a force sensor arranged in the housing 2 and for example mechanically linked to the mobile part 8 of the reservoir 6 to measure a tensile and / or compressive force in the direction of displacement of the part. tank mobile.

In particular, the force transducer is adapted to deflect under the application of compressive or tensile force. This strain can be measured, for example, by means of a strain gauge or strain gauge, and the applied force is determined from the strain thus measured. Starting from the measured force, the area of the movable part 8 being known, the control unit 10 can then deduce the corresponding pressure therefrom, the force being the product of the pressure and the area.

Alternatively, the sensor 11 is mechanically linked to the actuator, itself mechanically coupled with the movable part 8 of the reservoir 6, in particular integrally, so as to measure or calculate the pressure in the fluid circuit.

According to the invention, the housing 2 of the medical device 1 can also include a position or posture sensor 13 connected to the control unit 10 to detect the position or posture and / or the change of position or posture of part of the human or animal body or the whole body.

This posture sensor 13 is for example in the form of an accelerometer, in particular an accelerometer arranged to calculate linear accelerations along three orthogonal axes, a gyroscope and / or an inclinometer.

As illustrated in Figure 1, the reservoir 6 with its fixed part 7 and its movable part 8, the actuator 9, the control unit 10, the sensor 11 and the sensor 13 are all arranged in the housing 2 of the medical device. 1.

Likewise as shown, the medical device 1 including the housing 2, the cuff 3 and the tubular connection 5 are implanted in the human or animal body which is symbolized by the line 12 representing the skin of the body in FIG. 1.

The implanted medical device 1 can be remotely controlled by the patient by means of a wireless control system not implanted in the human or animal body of the remote control type.

In this case, provision is made for the remote control system to communicate with the medical device via radiofrequency waves or by electromagnetic induction.

The purpose of this communication may be to control the operation of the implanted device, for example to activate or deactivate it, open or close the occlusive cuff, configure the internal parameters of the medical device or obtain information from the device, for example knowing the state of the device or obtaining patient parameters measured by sensors implanted with the device. Alternatively, it is also envisaged to be able to control the medical device without having recourse to an external control system. In this case, the medical device is equipped with another sensor capable of detecting a mechanical action exerted on the body by the patient. This mechanical action can take the form of tapping of a certain duration and frequency representing a code corresponding to a command.

In Figure 2, there is illustrated a human body 12 in a standing position, front view with the medical device 1 according to the invention implanted.

In particular, it is shown that the housing 2 is implanted in the abdomen of the patient while the occlusive cuff 3 in the case of the artificial sphincter is arranged around the urethra well below the housing. They are connected by means of the tubular connection 5.

The housing 2 and the cuff 3 are therefore implanted at a distance from one another in the human body 12, and in particular at a different height when the patient is standing.

In what follows, we will name H the height difference between the housing 2 and the cuff in a standing position, in other words this corresponds to the distance between the housing 2 and the cuff 3 in the vertical direction (direction of gravity ) when the patient is in an upright position. According to the invention, the distance H is preferably at least 10 cm, more preferably a distance of at least 20 cm.

This height difference causes a pressure difference between the pressure in the housing 2 and the pressure in the cuff 3. This hydrostatic phenomenon is called "water column".

In particular, the housing 2 and the sleeve 3 are therefore located at a distance from one another in a direction substantially equivalent to a longitudinal direction of said body. This particular positioning induces a change in direction of the axis formed by the housing and the cuff during a change in body posture, especially when going from a standing to lying position.

In FIGS. 3 and 4, we respectively show the detail of the medical device 1 implanted in the body 12 of a male man seen in profile in a standing position and in the supine position.

As in Figure 2, Figure 3 shows the housing 2 and the cuff 3 implanted spaced apart from each other in the human body 12, with a height difference H when the patient is standing .

On the other hand, in FIG. 4, we show the housing 2 and the cuff 3 also implanted at a distance from one another in the human body 12, but this time with a difference in height h when the patient is supine. dorsal.

It is clearly shown that the difference in height H in the patient's standing position is different from the difference in height h in the supine position. In addition, in the case of the particular implantation of the medical device 1 for combating urinary incontinence, the difference in height H in a standing position is greater than the difference in height h in the supine position.

Due to the "water column" phenomenon, the pressure measured by the sensor 11 is different in the two positions.

In the standing position, and as the housing 2 is rigid and is hermetically linked to the end of the tubular connection connected to the reservoir, there is no direct transmission of the pressure due to the phenomenon of "column water ”, the pressure in the occlusive cuff 3 is therefore substantially equal to the pressure measured by the sensor 11 in the reservoir 6 plus the pressure corresponding to the water column H which is located above the cuff 3 and which, therefore, applies a corresponding pressure.

In dorsal decubitus (see figure 4), for the same reasons, the pressure in the occlusive cuff 3 is substantially equal to the pressure measured by the sensor 11 in the reservoir 6 plus the pressure corresponding to the water column h which is found above cuff 3.

In the case of a medical device 1 including a rigid case 2 and a cuff 3 of the deformable element type, the pressure in the cuff 3 is substantially the same in the standing position and in the supine position, while the pressure in the reservoir 6 measured by the sensor 11 is different in the two positions.

Advantageously, according to the invention, it is therefore taken advantage of this effect, specific to the medical device 1, to detect a posture and / or a change in posture of the body by means of the measurement or calculation of the pressure exerted in the reservoir. 6 as will be explained in more detail below.

It is important to note that the state-of-the-art three-part artificial urinary sphincter (the occlusive cuff, the control balloon and the pump) as described above does not allow this new function to be implemented.

Firstly because it does not include a sensor capable of measuring or calculating pressure, since it is a passive device, but also because of its different arrangement.

In fact, conversely, in this state-of-the-art device, the control balloon being flexible and deformable, there is a direct transmission of the pressure exerted by the water column to the occlusive cuff. In this case, it is the pressure exerted by the cuff that varies depending on the position while the pressure in the control balloon is the same in the standing position and in the supine position.

It is therefore not possible, as in the invention, to detect the position or the change in position as a function of the measured pressure. With reference to FIG. 5, we will now describe the method of detecting posture or change of posture according to the invention.

The detection method according to the invention provides for intraoperative steps, implantation steps and postoperative steps.

The intraoperative step 20 consists in providing the medical device 1 comprising the housing 2, the deformable element 3 and the tubular connection 5, with inside the housing 2, the reservoir 6 equipped with a fixed part 7 and of a movable part 8, an actuator 9, a control unit 10, a sensor 11 capable of measuring or calculating the pressure in the reservoir 6 and the posture sensor 13 as described above.

In step 21, during the operation, the surgeon implants this medical device 1 in order to obtain the configuration illustrated in FIG. 2 with the housing 2 implanted in the patient's abdomen, the occlusive cuff 3 remote from the housing 3 and arranged around the urethra 4.

In step 22, still during the operation, the surgeon connects the housing 2 to the occlusive cuff 3 by means of the tubular connection 5 to create the fluid circuit.

Between steps 21 and 22, there is also a step of purging the device (not detailed here) so as to evacuate the air and fill the device with fluid.

Once implanted, the medical device can preferably be configured postoperatively.

The following steps therefore describe the configuration of the medical device 1 to detect a posture and / or a change in body posture as a function of a variation in the pressure measured or calculated by the sensor 11.

In step 23, a calibration of the device is carried out. For example, this step may consist in asking the patient to take different and known postures such as going from a standing position to supine. During this step, the pressures measured by the sensor 11 are recorded in a table in the memory of the control unit 10 in correspondence with the positions, for example standing or lying down, or intermediate positions.

In this correspondence table, it is possible to define thresholds from which it is considered that the patient is in a determined position, for example lying down or standing.

It will be explained below how these measurements can be combined with the values measured by an accelerometer-type posture sensor to make the posture detection even more robust and more reliable.

The calibration step 23 can be performed once or several times over time to refine the measurements and make the detection more robust.

In step 24 of the detection method, the sensor 11 measures the pressure at regular time intervals, preferably frequent in order to be more responsive to posture change detections or to detect rapid posture changes. For example, the pressure is measured every 200 milliseconds.

In step 25, the current pressure value is compared with the previous pressure value and with the values recorded during calibration step 23 to detect a change in posture and therefore a new posture in step 26.

According to the invention, the control unit 10 is arranged to repeat steps 24, 25 and 26 at regular and frequent time intervals to detect changes in postures.

In a particular embodiment of the invention in which the housing 2 of the device includes a posture sensor 13 as described above, the measured values can be used in addition to the pressure values for the detection of posture.

This posture sensor 13, for example a three-axis accelerometer, also requires calibration in step 23 to allow the accelerometer to be virtually aligned with a known landmark. A virtual orientation makes it possible to match the 3 axes of the accelerometer with the axes related to the body, that is to say the upper-lower axis, the posterior-anterior axis and the left-right axis. This virtual orientation is preferably obtained by calculating reference change matrices when the patient takes predetermined postures, the corresponding accelerations are then recorded and the reference change matrix is deduced therefrom starting from the fact that the only acceleration at which is subject the body is gravitational acceleration.

If the medical device 1 is equipped with such a posture sensor 13, then in step 24 of the detection method according to the invention, the posture sensor 13 measures the posture at regular time intervals. . As before, it is preferable that the detection of the posture be frequent in order to be more responsive to changes. For example, posture is measured every 200 milliseconds.

Likewise according to this embodiment, in step 25, the value corresponding to the posture is compared. In the example, the current acceleration values are compared with the previous acceleration values and with the values recorded during calibration step 23 in order to detect a change in posture and therefore a new posture in step 26. Preferably , at this step, a measurement of the pressure carried out by the pressure sensor 11, also calibrated in step 23, confirms or invalidates the detection of posture or of a change in posture of the posture sensor 13. Finally, in this mode , the control unit 10 is also arranged to repeat steps 24, 25 and 26.

Preferably, in this particular embodiment, it is when a small variation is detected by the posture sensor 13 on the instantaneous measurements. acceleration, that a measurement of the pressure is carried out by the pressure sensor 11 making it possible to infer the current posture. This inference is validated or invalidated by the comparison between the value of the current pressure and the value of the pressure linked to the position inferred during the calibration step 23.

The posture sensor 13 being generally more energy efficient than the pressure sensor 11, this embodiment with a posture sensor 13 available, has the advantage of being able to save the overall energy used by the medical device when the sensor of pressure 11 is only used to confirm the posture measured by the posture sensor 13 and only in certain cases, for example when the variation measured by the posture sensor is small.

Consequently, the present invention therefore makes it possible to detect the posture or the change in posture more robust and more reliable to allow the pressure exerted on the natural duct by the deformable element to be best adapted and thus to avoid placing too much stress on it and to damage it.

The invention is also applicable to other fields. It is, for example, suitable for medical devices that apply a specific therapy such as a cardiac pacemaker or a neurostimulator.

Usually, a pacemaker provides electrical impulses to stimulate the heart muscles to make the heart beat faster when the heart rate is too slow.

In this case, the invention allowing the precise detection of the posture of the body or a change in the latter, it is possible to detect that a patient is in a lying position because he has just had a discomfort and that a therapy specific must be applied to change his heart rate.

Neurostimulators are implanted in the human body and connected to the spine. They are further configured to send electrical signals into the epidural space for chronic pain relief.

Neurostimulation works by interrupting pain-related signals between the spinal cord and the brain. The brain therefore no longer receives these signals and the patient no longer feels the pain.

In addition, certain pains are often made to intensify during a change in posture, especially when the patient relaxes, sits down or begins to walk. With the invention, it therefore becomes possible to adapt the various stimulation parameters to these variations in posture.

Unlike devices for combating urinary incontinence, in the case of the cardiac pacemaker or the neurostimulator, the deformable element is no longer arranged around a natural duct to be occluded. But in these applications, it takes the form of a deformable balloon-type element with no other function than that of being able to reproduce the water column phenomenon. It is therefore still disposed at the end of the tubular connection and still implanted in the body at a distance from the housing at a different height when the patient is standing. As previously described, it is possible to use a different pressure measurement depending on the position and therefore to detect a change in posture. The other elements of the medical device are similar and operate similarly to what has been described above.

It is understood that the embodiments described above correspond to specific and non-limiting examples and that various modifications can be made without departing from the invention as claimed.

Claims

1. Medical device (1) arranged to be implanted in a human or animal body (12), comprising a housing (2), at least one deformable element (3), a tubular connection (5) providing a fluid connection between the housing (2) and the deformable element (3) to form a fluidic circuit, and at least one sensor (11) able to measure or calculate a pressure in the fluidic circuit, the housing (2) and the deformable element (3) being adapted to be implanted in the human or animal body distant from each other, the medical device (1) being characterized in that it is configured to detect a position and / or a change of position of at least a part of said body as a function of a variation in the pressure measured or calculated by the sensor.

2. Medical device according to claim 1, wherein the housing (2) is rigid and hermetically connected to one end of said tubular connection (5).

3. A medical device according to any preceding claim, wherein the deformable element (3) is inflatable.

4. Medical device according to any one of the preceding claims, wherein the sensor (11) is arranged inside the housing (2) and able to measure or calculate the pressure in the deformable element (3).

5. Medical device according to the preceding claim, wherein the housing (2) comprises a reservoir (6) of fluid including a movable part (8) and an actuator (9) of the movable part to vary a volume of said reservoir, the sensor (11) capable of measuring or calculating the pressure being mechanically linked to said movable part (8) and / or to the actuator (9), in particular integrally.

6. Medical device according to any one of the preceding claims, wherein the housing (2) and the deformable element (3) are adapted to be implanted in the human or animal body distant from each other in a direction. which varies during a change in position of at least part of said body, in particular when changing from a standing to lying position.

7. Medical device according to the preceding claim, wherein the housing (2) and the deformable element (3) are adapted to be implanted in the human or animal body distant from each other in a direction substantially equivalent to a longitudinal direction of said body.

8. Medical device according to any one of the preceding claims, wherein the housing (2) and the deformable element (3) are adapted to be implanted in the human or animal body distant from each other by a distance of at least 5 cm, preferably a distance of at least 10 cm, more preferably a distance of at least 20 cm.

9. A medical device according to any preceding claim, wherein the device (1) comprises a position sensor (13) of at least part of said human or animal body.

10. Medical device according to any one of claims 1 to 8, wherein the device comprises a position sensor (13) of at least a part of the human or animal body, the device being configured to detect the position and / or the change in position of at least part of said body from a measurement or calculation of pressure by the sensor (11) capable of measuring or calculating the pressure in the fluidic circuit and to confirm said position and / or said change in position from a measurement of the position sensor (13).

11. Medical device according to any one of claims 1 to 8, wherein the device comprises a position sensor (13) of at least a part of the human or animal body, the device being configured to detect the position and / or the change of position of at least a part of said body by the position sensor (13) and to confirm said position and / or said change of position from a measurement or calculation of the pressure in the fluidic circuit by the sensor (11) capable of measuring or calculating the pressure.

12. Medical device according to any one of claims 9 to 11, wherein the position sensor (13) is chosen from: an accelerometer, in particular an accelerometer arranged to calculate the linear accelerations along three orthogonal axes, a gyroscope and / or an inclinometer.

13. Medical device according to any one of the preceding claims, in which the device comprises a control unit (10) configured to perform at least one of the following operations: measuring or calculating a pressure by means of the sensor capable of measuring or calculating a pressure. pressure, detecting a position or a change in position of at least one part of said body as a function of a position sensor of at least one part of said human or animal body and / or of the sensor capable of measuring or calculating the pressure.

14. The medical device of claim 13 in combination with claim 5, wherein the control unit (10) is configured to control the actuator to move the movable part of the reservoir and vary the volume of said reservoir.

15. A medical device according to any one of the preceding claims, wherein the deformable element (3) is an occlusive cuff arranged to close a natural duct (4) of said human or animal body.

16. Medical device according to any one of claims 1 to 15, wherein the device is configured to be implanted in a human or animal body to close a natural duct (4) of said human or animal body included among at least: a urethra , gastric duct, colon or rectum.

17. A medical device according to any one of claims 1 to 14, wherein the device is configured to act as a pacemaker or as a neurostimulator.

18. Method of detecting a position and / or a change of position of at least a part of a human or animal body, in which said body comprises a medical device (1) comprising a housing (2), at least one deformable element (3), a tubular connection (11) providing a fluidic connection between the housing (2) and the deformable element (3) to form a fluidic circuit, and at least one sensor (11) capable of measuring or calculate a pressure in the fluidic circuit, the housing (2) and the deformable element (3) being arranged at a distance from each other, in which a position and / or a change of position of at least at least one part of said body as a function of a variation in the pressure measured or calculated by the sensor (11) capable of measuring or calculating a pressure.

19. Detection method according to the preceding claim, wherein the housing (2) and the deformable element (3; 31; 41) are distant from each other in a direction which varies during a change of position. at least part of said body, in particular when going from a standing to lying position.

20. Detection method according to the preceding claim, wherein the housing (2) and the deformable element (3; 31; 41) are spaced from each other in a direction substantially equivalent to a longitudinal direction of said body.

21. Detection method according to any one of claims 18 to 20, wherein the medical device comprises a control unit (10) which performs at least one of the following operations: measuring or calculating a pressure by means of the sensor (11). capable of measuring or calculating a pressure, - detecting a position and / or a change in position of at least part of said body as a function of a position sensor (13) and / or of the sensor (11) capable of measuring or calculate the pressure.

22. A detection method according to claim 21, wherein the control unit (10) is configured to control an actuator (9) to move a movable part (8) of a tank (6) and to vary the volume of said tank. reservoir.

23. Detection method according to any one of claims 18 to 22, in which a position sensor (13) capable of detecting a position and / or a change in position of at least a part of the body is calibrated by means of the sensor (11) capable of measuring or calculating pressure.

24. A detection method according to any one of claims 18 to 23, wherein the deformable element (3) is inflatable and selected from an occlusive cuff arranged to close a natural duct of said human or animal body.